The Food and Drug Administration (FDA) has proposed a barcode system that would allow the agency to track the failures of potentially defective medical devices with better efficiency.
Using billing and medical records and tagged devices, the FDA believes it can avoid the pitfalls that have recently caused the agency to come under increased scrutiny of the systems it uses to approve new medical devices, according to a report this week from Wall Street Journal. In the last few years, the repeated and catastrophic failures of certain medical devices have left thousands of Americans questioning just how these devices reached the market, most without any warning of potential dangers.
For devices like metal-on-metal hip implants like the DePuy Orthopaedics ASR and Pinnacle models, most transvaginal mesh devices, and faulty cardiac defibrillator leads, their approval through the agency’s 510(k) fast-track approval system has allowed them to reach the market with very little pre-market safety testing and almost no post-market testing being conducted. As evidence, it has taken Congressional action to get the makers of transvaginal mesh and all-metal hip implants to conduct proper safety testing on their devices.
Unlike other medical devices regulatory agencies around the world that utilize national registries and databases to track the viability, effectiveness, and safety of medical devices once they’ve been received by patients, the FDA relies solely on reported incidents to the agency from physicians and surgeons or a voluntary national record filled with reports from individual recipients that the agency only relies upon to discover alarming trends but must still investigate on its own.
To create a more official registry of medical device performance, a system that could track in near-real time, each medical device would be given a barcode serving as its Universal Device Identifier (UDI). The UDI would enable the FDA to track device failures as they’re happening. If a recipient is experiencing trouble with a certain device tagged with a UDI and visits a doctor, the FDA is more likely to receive clearer information on exactly what went wrong with a device as it happens. For the system to work, WSJ.com reports, the agency would need the ability to search databases of medical records through either veterans’ benefits recipients, Medicare records, and those submitted by insurance companies.
For as flawed as the FDA’s post-market tracking system of medical devices is, the fact remains these defective and dangerous products are reaching the public without having undergone much or any pre-market testing, courtesy of that fast-track system. While a better post-market tracking system is likely necessary to ensure better public safety, giving the agency the ability to note truly unexpected trends with medical devices, like those posing risks to specific patients, many of the devices that prompted this call for a better system reached the market with very little testing prior.
And in much of the legal action filed by the patients who’ve been injured or died as a result of these failures against the makers of these devices, they commonly claim the device manufacturers knew of the problems and flaws with the product prior to getting them approved by the FDA.
The report indicates the FDA proposed its system to the White House’s Office of Budget Management (OMB) at least 10 months ago but has not received word of any action on it. An OMB official told Wall Street Journal it does not comment on proposals received by the office.